Practical guide to hot-melt extrusion : continous manufacturing and scale-up / editor, Mohammed Maniruzzaman.

Format:

Book

Contributor:

Maniruzzaman, Mohammed, editor.

Language:

English

Subjects (All):

Pharmaceutical technology.

Physical Description:

1 online resource (249 p.)

Place of Publication:

Shrewsbury : Smithers Rapra, 2015.

Summary:

Over the past few decades, hot-melt extrusion (HME) techniques have been shown to exhibit remarkable potential for the manufacture of various pharmaceutical products. HME is an emerging processing technology used primarily for the manufacture of pharmaceutical solid dispersions, combining the advantages of a solvent-free process with fewer production steps making it suitable for easy to scale-up and continuous manufacturing applications. A single unit HME based operation, employing heat and mechanical shear, has displayed a significant potential to retain the stability even of thermo-labile therapeutics e.g., proteins. HME has now explicitly been established from a quality-by-design viewpoint for in-line data monitoring as per the recent guidelines issued by the US Food and Drugs Administration (FDA). This book will focus primarily on the foregoing subject areas and will be of significant interest to a broad/interdisciplinary readership across the industries and academia for, (but not limited to) the following reasons: Emerging HME processes and applications for multiple drug delivery. Solid-state engineering, solubility enhancement, controlled release, taste masking and sustained release case studies from a continuous manufacturing view-point. Means to explore the potential of continuous manufacture of co-crystals for promoting solvent free production methods. Scale-up case study and issue considerations and studies on the regulatory guidelines (FDA) for continuous manufacturing involving emerging HME techniques."

Contents:

Preface; Contents; Contributors; 1 Introduction to Hot-Melt Extrusion, Continuous Manufacturing: Scale-up via Hot-Melt Extrusion; 1 Background; 1.1 Introduction; 1.1.1 Hot-Melt Extrusion Process Technology; 1.1.2 Equipment; 1.1.3 Benefits and Drawbacks to Hot-Melt Extrusion; 1.1.4 Application of Hot-Melt Extrusion; 1.1.5 Materials used in Hot-Melt Extrusion Processes; 1.1.6 Development of Sustained-release Formulations; 1.1.7 Marketed Products; 1.2 Continuous Manufacturing; 1.3 Scale-up via Hot-Melt Process; 1.3.1 Case Study: Scale-up of a Hot-Melt Extrusion Process using Soluplus as Carrier

1.4 ConclusionsReferences; 2 Hot-Melt Extrusion as Continuous Manufacturing Technique, Current Trends and Future Perspectives; 2.1 Hot-Melt Extrusion as Continuous Manufacturing Technique; 2.1.1 Hot-Melt Extrusion Equipment; 2.1.2 Single-screw Extruder; 2.1.3 Twin-screw Extruders; 2.1.4 Role of Glass Transition Temperature; 2.1.5 Role of Mechanical Parameters; 2.1.6 Use of Plasticisers or Surfactants; 2.1.7 Challenges and Opportunities; 2.2 Background Information on Batch Processing; 2.2.1 Past and Future Trends of Continuous Manufacturing; 2.2.2 Conventional Batch Process Design

2.2.3 Production Parameters2.2.4 Production Parameters in Batch Processing; 2.2.4.1 Active Pharmaceutical Ingredient(s) Manufacturing Site; 2.2.4.2 Formulation Development; 2.2.4.3 Industrial Scale-up; 2.2.4.4 Regulatory Guidelines; 2.2.5 Validation of Batch Processing; 2.2.6 In-line Continuous Monitoring Techniques; 2.3 Assimilation of Complete Quality-by-Design Models; 2.3.1 Chief Modification in Procedural Expertise for Continuous Manufacturing; 2.3.2 Process Parameters for Preformulation for Hot-Melt Extrusion; 2.3.3 Implementation of a New Product Development Process

2.3.3.1 Modelling Simulation of Hot-Melt Extrusion Process2.3.4 Flow Chart Model for Continuous Hot-Melt Extrusion based Pharmaceutical Manufacturing Process; 2.3.5 Foremost Alteration in Structural Provisions for Quality and Technical Operations; 2.3.6 Potential Benefits of Continuous Hot-Melt Extrusion Manufacturing; 2.3.7 Regulatory Issues Related to Hot-Melt Extrusion; 2.3.8 Process Analytical Technology Framework; 2.4 Conclusion; References; 3 Co-extrusion as a Novel Approach in Continuous Manufacturing Compliance; 3 Background; 3.1 Introduction

3.2 Applications of Co-extrusion via Hot-Melt Extrusion in Continuous Manufacturing3.2.1 Problem Encountered During Co-extrusion; 3.2.2 Variation of the Die Temperature; 3.2.3 Swelling of the Die; 3.2.4 Viscosity Matching; 3.2.5 Adhesion; 3.2.6 Interdiffusion; 3.2.7 Delamination; 3.3 Pharmaceutical Applications; 3.3.1 Pharmaceutical Significance of the Co-extrusion Technique; 3.4 Case Study; 3.5 Conclusions; References; 4 Solid-state Engineering of Drugs using Melt Extrusion in Continuous Process; 4 Introduction; 4.1 Dissolution Enhancement; 4.1.1 Use of Novel Inorganic Excipients

4.1.2 Use of Polymers to Enhance Dissolutions of Poorly Water-soluble Active Pharmaceutical Ingredients

Notes:

Includes index.

Description based on online resource; title from PDF title page (ebrary, viewed May 3, 2016).

ISBN:

1-68015-893-7

1-910242-12-8